Fresenius Kabi Ltd & Calea (UK) Ltd.
| Used as: | Aseptic Compounding & Dispensing Cleanroom |
| Location: | Runcorn, United Kingdom |
| Sector: | Pharmaceutical |
| Solution: | Modular Panel |
- The largest compounding and dispensing facility in the United Kingdom
- Used for the preparation, processing, dispensing, packing and storage of aseptic products
- The facility combines three separate sites under one roof and sharing one platform of operational excellence
- 2,260m2 high efficiency modular panel cleanroom installed in a warehouse environment
- 15% saving compared to traditional construction methods
"Fresenius Kabi is focused on the growing demand for compounding services within the healthcare market and we understand the importance of uncompromising quality in the service that we offer. We enjoyed working with Clean Modules and by combining both companies' experience and expertise we have created a facility that will provide the needed capacity in an efficient way. We are delighted with Clean Modules' management of the project and are very proud of our new unit."
Guy Topping, International Compounding Manager for Fresenius Kabi Ltd
Technical Specification:
The aseptic compounding and dispensing production facility houses an EU GMP Grade B Total Parenteral Nutrition (TPN) compounding suite, EU GMP Grade B batch and fast compounding suites with a total of ten Laminar Air Flow (LAF) cabinets and two 3-glove isolators. The compounding suites are supported by a 395m2 assembly area, a 542m2 packing and dispensing room and a 300m2 EU GMP Grade C support area. Besides the facilities for large-scale production, the new facility also houses a Prescription-Only-Medicine (POM) pharmacy.
Production efficiency from the first few weeks was significantly ahead of expectation. This is particularly important, since demand is expected to grow significantly during the first four years. The workflow of raw materials and the daily dispatch of individual orders (ranging from support equipment to cold-stored individual prescriptions) was a major element of the design phase. Clean Modules was integral to this process and provided many bespoke solutions including process flow, the overall lay-out conveyors and trolley hatches.
A 15% saving on standard installation costs was achieved by the use of Clean Modules' modular panel system. The modular panel system ensured the build was completed within the agreed timetable of just eight months, from starting on site to the MHRA inspection. The result is a highly versatile and space-efficient facility that ensures Calea UK and Fresenius Kabi's competitive position within the pharmaceutical compounding and dispensing market.
Additionally, in line with today's rising energy costs and environmental policies, a 31% energy saving has been achieved through the careful design of the air handling plant and through the use of a novel re-circulating "piggyback" system. This, coupled with the latest facility monitoring system of all major parameters, including particles, temperature and humidity, provides an efficient facility complying with all the latest regulatory requirements.